RAINBOW-Hx trial

Phase 1

Recruiting

• Conditions: cerebral hemorrhage; Chronic, hemorrhage, brain; D002543

• Registration Number: JPRN-jRCT2013230053
• Lead Sponsor: Kawabori Masahito

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-06
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Age between 20 and 70 years
2. Clinical diagnosis of intracerebral hemorrhage 12 month or more from onset
3. Hemorrhagic location of unilateral basal ganglia or thalamus
4. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage III or IV
5. No significant neurological impairment before hemorrhage (Pre-hemorrhagic mRS of 0 or 1)
6. Subjects who can give informed consent by its self

Exclusion Criteria

1. Severe microbleeds
2. Hemorrhagic cavity less than 2 mL
3. The hemorrhage is due to arteriovenous malformation, cerebral aneurysm, and Moyamoya disease
4. Subject showing obvious communication between the hemorrhagic cavity and lateral ventricle on MRI
5. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)
6. Subject's body weight less than 45 kg for male and 40kg for female

Study & Design

• Study Type: Interventional
• Study Design: Not specified